Measurement of Total Hemoglobin by Pulse Oximetry in Neonatal Population

Assess ability of Masimo SpHb sensor to demonstrate robust performance on various sensor application sites on neonates/infants

Study Overview

• Status: Completed
• Conditions: Anemia
• Intervention / Treatment: Device: Investigational Rainbow SpHb sensor

• Study Type: Interventional
• Enrollment (Actual): 128
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Orange, California, United States, 92868
      • Children's Hospital of Orange County

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 3 months (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Male or female newborn infants of any gestational age requiring at least one (1) blood draw as part of their routine care.
• Ages: Newborn infants less than 16 weeks postnatal age.
• Weight: Range from 500 g to 10 kg.
• Able to obtain written informed consent from parents or legal guardians

Exclusion Criteria:

• Neonatal patients with abnormalities at the planned application sites that would interfere with transilluminating the foot or hand like unusual deformities of limbs, absence of feet, severe edema, localized infections, and other.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Neonatal Test Subjects; All test subjects in this group are neonatal patients who will receive a investigational Rainbow SpHb sensor.	Device: Investigational Rainbow SpHb sensor; Investigational Rainbow SpHb sensor

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assess ability of Masimo SpHb sensor to demonstrate robust performance on various sensor application sites on neonates/infants	To study the SpHb sensor in neonatal population.	duration of surgery

Collaborators and Investigators

• Sponsor: Masimo Corporation

Study record dates

Study Major Dates

• Study Start (Actual): July 23, 2013
• Primary Completion (Actual): April 20, 2017
• Study Completion (Actual): April 20, 2017

Study Registration Dates

• First Submitted: April 14, 2017
• First Submitted That Met QC Criteria: April 18, 2017
• First Posted (Actual): April 19, 2017

Study Record Updates

• Last Update Posted (Actual): April 28, 2021
• Last Update Submitted That Met QC Criteria: April 26, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: CHOC0002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes